Endoscopic lithotomy method and device

Abstract

The present disclosure provides an endoscopic device and method that may include a steerable sheath, a control wire disposed within the steerable sheath, and a basket disposed on the control wire. The steerable sheath may be actuated to form a bend, such that forward movement of the control wire can cause the basket to extend out of the steerable sheath and expand, and retraction of the control wire can cause the basket to retract into the steerable sheath and contract.

Description

[Technical Field]

[0001] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with government support under Grant No. 1R44EB031741-01 awarded by the National Institutes of Health (NIH). The U.S. government has certain rights in this invention.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a non-provisional application and claims priority to U.S. Provisional Patent Application No. 63 / 419,842, filed October 27, 2022, entitled "METHOD AND APPARATUS FOR ENDOSCOPIC STONE Retrieval," which is incorporated herein by reference in its entirety.

[0003] The present disclosure relates generally to instruments and methods for endoscopic surgery, and more particularly to providing an endoscopic instrument for performing minimally invasive ureteroscopic kidney stone removal procedures within a patient. [Background technology]

[0004] Each year, 3.5 million people suffer from kidney stones, and one in five (approximately 700,000) require treatment. Because 63% of these 700,000 patients have small stones, the current standard of care is effective, often involving flexible ureteroscopy. A typical ureteroscopy procedure involves passing an endoscope directly through the urethra, expanding it, and into the upper urinary tract to remove the kidney stone. Depending on the size of the stone to be removed, ureteroscopy may require endoscopic laser lithotripsy (e.g., using a laser to break the kidney stone into pieces), followed by the deployment of a flexible ureteroscopic kidney stone basket from the endoscope and the use of the endoscope to capture and remove the fragments. However, as kidney stones increase in size, surgeons face a complex dilemma regarding how to treat the remaining 37% of patients (approximately 260,000 patients annually in the United States alone) with large stones (e.g., 11 mm or larger in diameter), for whom typical surgery becomes difficult and ineffective. For example, lack of dexterity in aiming the laser and using the basket to capture stone fragments to perform laser lithotripsy can result in procedures involving large stones that are relatively long in duration (e.g., greater than two hours) and are highly fraught with complications (e.g., risk of complications associated with the prolonged presence of the endoscope within the patient). This is particularly true for lower pole cases (e.g., cases where the stone is located in the lower renal calyx), which may be the most common type of kidney stone suffered by patients. In such cases, the anatomical location of the kidney stones makes it very difficult to effectively capture all of the stones with the basket due to the aforementioned lack of dexterity.

[0005] Many such baskets have been developed to enable the capture of kidney stones, including standard "tipped" baskets, "tipless" designs, and "end-engaging" designs. These baskets all operate on a standard principle: a "relaxed" configuration of the basket is placed around the stone (e.g., so that the stone is within the range of the multiple pre-curved wires comprising the basket), the pre-curved wires are retracted into an outer tube or set of tubes to transition the basket to a "collapsed" configuration, trapping the stone, and the basket is then withdrawn from the patient. A drawback of this prior art is that the basket can only be inserted and retracted in a straight line into and out of the surgical field, leading to the dexterity issues discussed above. This is particularly problematic in the lower renal calyx, where stones may be located near corners of the calyx that are not directly accessible by the ureteroscope. In this situation, the physician must attempt to passively bias the basket into the calyx, which requires the basket cage to "bounce" against the tissue, repeatedly attempting and reorienting the basket into the calyx, which can be a very tedious and frustrating process that significantly increases surgical time and can lead to patient trauma due to the repeated interaction between the basket and the patient's tissue.

[0006] Therefore, what is needed are improved instruments and methods for in-patient ureteroscopic kidney stone removal. Summary of the Invention [Means for solving the problem]

[0007] This Summary is provided to introduce some concepts in a simplified form that are more fully described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0008] One aspect of the present disclosure is a device for removing anatomical objects (e.g., kidney stones) from within a patient by deploying a basket from a steerable sheath insertable into the patient. For example, the devices and methods described herein may provide a method for removing kidney stones and other anatomical objects that may need to be removed from a patient with the increased dexterity provided by the steerable sheath. The devices described herein may therefore facilitate kidney stone removal with reduced surgical time and fewer complications.

[0009] The device includes a steerable sheath (e.g., tube, arm, tool, member, etc.) through which the basket and control wires coupled to the basket can extend. The steerable sheath can be actuated to form a bend to steer the distal end of the steerable sheath, thereby steering the basket located on the steerable sheath when deployed through the distal tip into an expanded configuration; the basket can be used to capture an object and then retracted into the lumen of the steerable sheath to a collapsed state holding the member. The steerable sheath can then be retracted from the patient to remove the object.

[0010] In some embodiments, the steerable sheath has a concentric tube structure including nested concentric tubes, whereby the steerable sheath can be actuated to form a bend by applying an axial force to the concentric tubes. A control wire can be disposed within the steerable sheath and movable within the steerable sheath along the longitudinal axis of the steerable sheath. The basket can be disposed on the control wire and can include several wires. Thus, forward movement of the control wire causes the basket to expand and protrude from the opening formed by the distal end of the steerable sheath, while retraction of the control wire causes the basket to retract and contract within the opening.

[0011] Another embodiment of the present disclosure is a method for extracting an anatomical object from within a patient. A steerable sheath includes a basket, the basket coupled to a control wire, the control wire movable along a longitudinal axis of the steerable sheath. The anatomical object (which may be a kidney stone) is retained by the basket by actuating the steerable sheath to form a bend and expanding and / or contracting the basket by advancing and / or retracting the control wire (respectively).

[0012] Various other objects, advantages and features of the present disclosure will become readily apparent to those skilled in the art upon review of the following drawings and description of the preferred embodiment. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a perspective view of a tube assembly of an endoscopic stone removal device according to some embodiments of the present disclosure. FIG. [Figure 2] 2 is a perspective view of a method of assembling the tube assembly of FIG. 1 according to some embodiments of the present disclosure. [Figure 3A] FIG. 10 is a side view of an embodiment of a first flexible tube and a second flexible tube assembled to form a steerable sheath for endoscopic lithotripsy, according to some embodiments of the present disclosure. [Figure 3B] FIG. 3B is a side view of the first and second flexible tubes of FIG. 3A assembled to form a steerable sheath, according to some embodiments. [Figure 3C] FIG. 3C is a side view of the assembled steerable sheath of FIG. 3B actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 3D] FIG. 3C is a side view of the assembled steerable sheath of FIG. 3B actuated to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 3E]FIG. 10 is a perspective view of a tube assembly of an endoscopic stone removal device, wherein a steerable sheath of the device is actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 3F] FIG. 10 is a perspective view of a tube assembly of an endoscopic stone removal device, wherein a steerable sheath of the device is actuated to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 4A] FIG. 10 is a side cross-sectional view of a tube assembly of an endoscopic stone removal device, wherein a steerable sheath of the device is actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 4B] FIG. 10 is a side cross-sectional view of a tube assembly of an endoscopic stone removal device, wherein a steerable sheath of the device is actuated to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 4C] 1 is an axial cross-sectional view of a tube assembly of an endoscopic stone removal device according to some embodiments of the present disclosure. [Figure 5A] 1A-1C are side views of first and second flexible tubes for a steerable sheath according to some embodiments of the present disclosure. [Figure 5B] FIG. 10 is a side view of a first flexible tube and a second flexible tube for a steerable sheath according to some embodiments of the present disclosure. [Figure 5C] FIG. 10 is a side view of a first flexible tube and a second flexible tube for a steerable sheath according to some embodiments of the present disclosure. [Figure 5D] FIG. 10 is a side view of a tube assembly of an endoscopic stone removal device, with a steerable sheath of the device actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 5E] FIG. 10 is a side view of a tube assembly of an endoscopic stone removal device, with a steerable sheath of the device actuated to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 5F]FIG. 10 is a side view of a tube assembly of an endoscopic stone removal device, with a steerable sheath of the device actuated to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 6A] FIG. 1 is a detailed perspective view of a tube assembly for endoscopic stone removal, according to some embodiments of the present disclosure; [Figure 6B] FIG. 6B is a perspective view of the tube assembly of FIG. 6A illustrating the use of a basket of the tube assembly to capture a kidney stone, according to some embodiments of the present disclosure. [Figure 7A] FIG. 1 is a perspective view of an endoscopic stone removal basket in a collapsed state, according to some embodiments of the present disclosure. [Figure 7B] FIG. 7B is a perspective view of the basket of FIG. 7A in an open state, according to some embodiments of the present disclosure. [Figure 7C] 12A is a perspective view of a tube assembly for endoscopic stone removal with a basket advanced to a released state, according to some embodiments of the present disclosure; FIG. [Figure 7D] 12A is a perspective view of an endoscopic stone removal tube assembly with a basket retracted to a collapsed state according to some embodiments of the present disclosure; FIG. [Figure 7E] 12A is a perspective view of a tube assembly for endoscopic stone removal with a basket advanced to a released state, according to some embodiments of the present disclosure; FIG. [Figure 7F] 12A is a perspective view of an endoscopic stone removal tube assembly with a basket retracted to a collapsed state according to some embodiments of the present disclosure; FIG. [Figure 8A] 1A-1C are schematic diagrams of an endoscopic stone removal device illustrating the extraction of a kidney stone from within a patient's anatomy, according to some embodiments. [Figure 8B] FIG. 8B is a detailed perspective view of the basket of the device of FIG. 8A according to some embodiments of the present disclosure. [Figure 9A] FIG. 1 is a perspective view of an endoscopic stone removal device shown with a user interface coupled with a tube assembly, according to some embodiments of the present disclosure. [Figure 9B]9B is a side cross-sectional view of the device of FIG. 9A according to some embodiments of the present disclosure. [Figure 9C] 9B is a side cross-sectional view of the device of FIG. 9A according to some embodiments of the present disclosure. [Figure 10] FIG. 1 is a perspective view of an endoscopic stone removal device shown with a user interface coupled with a tube assembly and a ureteroscope, according to some embodiments of the present disclosure. [Figure 11A] FIG. 9B is a perspective view of the device of FIG. 9A according to some embodiments of the present disclosure. [Figure 11B] FIG. 9B is a perspective view of the device of FIG. 9A being actuated to advance the basket, according to some embodiments of the present disclosure. [Figure 11C] FIG. 9B is a perspective view of the device of FIG. 9A, with the steerable sheath of the device actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 11D] FIG. 9B is a perspective view of the device of FIG. 9A, with the steerable sheath of the device actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 11E] FIG. 11 is a perspective view of the device of FIG. 10 being actuated to advance the basket, according to some embodiments of the present disclosure. [Figure 11F] FIG. 11 is a perspective view of the device of FIG. 10 with the steerable sheath of the device actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 11G] FIG. 11 is a perspective view of the device of FIG. 10 with the steerable sheath of the device actuated to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 11H] FIG. 11 is a perspective view of the device of FIG. 10, rotating the user interface to rotate the basket, according to some embodiments of the present disclosure. [Figure 12A] 1 is a side cross-sectional view of a user interface for endoscopic stone removal according to some embodiments of the present disclosure. FIG. [Figure 12B]FIG. 12B is a side view illustrating the user interface of FIG. 12A engaging with a ureteroscope, according to some embodiments of the present disclosure. [Figure 12C] FIG. 12B is a side view illustrating the user interface of FIG. 12A advancing to engage the ureteroscope, according to some embodiments of the present disclosure. [Figure 12D] FIG. 12B is a side view illustrating the user interface of FIG. 12A engaging with a ureteroscope, according to some embodiments of the present disclosure. [Figure 12E] FIG. 12B is a side view illustrating the user interface of FIG. 12A engaging with a ureteroscope, according to some embodiments of the present disclosure. [Figure 12F] FIG. 11 is a perspective view of the device of FIG. 10 with the user interface pushed toward the ureteroscope and the steerable sheath protruding from the ureteroscope tube, according to some embodiments of the present disclosure. [Figure 13A] FIG. 10 is a side cross-sectional view of an alternative user interface of an endoscopic stone removal device in which a lever is actuated to cause a steerable sheath of the device to form a bend in a first direction, according to some embodiments of the present disclosure. [Figure 13B] FIG. 13B is a detailed perspective view of the steerable sheath of FIG. 13A according to some embodiments of the present disclosure. [Figure 13C] FIG. 10 is a side cross-sectional view of an alternative user interface of an endoscopic stone removal device in which a lever is actuated to cause a steerable sheath of the device to form a bend in a second direction, according to some embodiments of the present disclosure. [Figure 13D] FIG. 13D is a detailed perspective view of the steerable sheath of FIG. 13C according to some embodiments of the present disclosure. [Figure 13E] 13A is a side cross-sectional view of an alternative user interface of an endoscopic stone removal device with a trigger actuated to advance a basket, according to some embodiments of the present disclosure. FIG. [Figure 13F] FIG. 13F is a detailed perspective view of the steerable sheath of FIG. 13E according to some embodiments of the present disclosure. [Figure 14A] 1 is a perspective view of a rigid device for endoscopic stone removal, according to some embodiments of the present disclosure; FIG. [Figure 14B] FIG. 14B is a detailed perspective view of the steerable sheath of FIG. 14A according to some embodiments of the present disclosure. [Figure 15] FIG. 1 is a perspective view of a robotic actuator of an apparatus for endoscopic stone removal, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014] While the following provides detailed descriptions of making and using various embodiments of the invention, it should be understood that the invention provides many applicable inventive concepts that can be embodied in a variety of specific contexts. The specific embodiments described herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention. Those skilled in the art will recognize that there are various equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the invention and are covered by the claims.

[0015] In the drawings, for the sake of clarity, not all reference numbers are included in every drawing. Furthermore, positional terms such as "upper," "lower," "side," "top," "bottom," etc. refer to the device in the orientation shown in the drawings. As will be appreciated by those skilled in the art, the device may be in other orientations when in use.

[0016] Referring generally to the drawings, the present disclosure provides an apparatus for extracting stones (e.g., multiple stones, kidney stones, gallstones, etc.) from within a patient (device) 100. In various embodiments, such an apparatus includes a tubing assembly 10 incorporating a steerable sheath 12. As described herein, the steerable sheath 12 may be configured as an agonist-antagonist concentric tube manipulator and, therefore, may be actuatable (e.g., controllable, displaceable, translatable, rotatable, configured to be actuated, capable of being actuated, etc.) to form a bend (e.g., curve, deflection, etc.) such that the distal end 22 of the steerable sheath 12 is steered (e.g., deflected) toward an anatomical region (e.g., a surgical site) to perform stone extraction as provided herein. For example, the steerable sheath 12 may be configured as a concentrically nested (e.g., concentrically nested) first flexible tube 28 within a second flexible tube 26. The first and second flexible tubes 28, 26 may include nested concentric tube structures (e.g., asymmetrically arranged). Each of the first and second flexible tubes 28, 26 may include a rigid portion along its longitudinal length and a flexible portion along its longitudinal length. In another embodiment, each of the first and second flexible tubes 28, 26 is rigid along its entire length except for a flexible portion at or near the distal end 22 of the steerable sheath 12. Thus, each of the first and second flexible tubes 28, 26 may be flexible in that it includes a flexible portion. As will be described in more detail below, each of the first and second flexible tubes 28, 26 may be configured with asymmetric flexibility characteristics to employ a concentric agonist-antagonist actuation scheme.

[0017] In some embodiments, the tube assembly 10 further includes a basket 50 coupled to a control wire 52, which may be manipulated to extract a stone. The control wire 52 may be disposed within the steerable sheath 12 and may be movable therein along a longitudinal axis 92 of the steerable sheath 12 (as shown in FIGS. 3C and 3D ). For example, at least a portion of the control wire 52 may be disposed within the lumen of the steerable sheath 12. Thus, the steerable sheath 12 can be used to control the position of the basket 50 to extract a stone. For example, the basket 50 may be disposed on the control wire 54 and may be at least partially disposed within the steerable sheath 12. Thus, the device 100 can be used as a minimally invasive medical device for removing stones from a patient's renal, ureteral, or biliary system. Although generally described in the context of removing stones from within a patient's kidney (and the calyces therein), it will be appreciated that the devices and methods described herein may be applied to removing a wide variety of anatomical objects in a variety of anatomical environments, structures, and situations.

[0018] 1, there is shown a tube assembly 10 according to some embodiments of the present disclosure. As mentioned above, the tube assembly 10 may include a steerable sheath 12, a control wire 52 disposed at least in part within the steerable sheath 12, and a basket 50 coupled to the control wire 52.

[0019] 2, an exemplary method of realizing the tube assembly 10 is shown, according to some embodiments of the present disclosure. The control wire 52 (to which the basket 50 is coupled) may be fed through the lumen of the first flexible tube 28, thereby disposing the control wire 52 within the first flexible tube 28. The first flexible tube 28 (and the control wire 52 therein) may then be fed through the second flexible tube 26, thereby disposing the first flexible tube 28 (and the control wire 52 therein) within the second flexible tube 26, thereby disposing the control wire 52 within the steerable tool 12.

[0020] 3A-3F, the steerable sheath 12 according to various embodiments of the present disclosure is shown in detail. In some embodiments, the first and second flexible tubes 28, 26 are connected or secured to one another (e.g., by welding or adhesive) at or around the distal end 22 of the steerable sheath 12 (e.g., at the distal ends of the first and second flexible tubes 28, 26). In other embodiments, the distal ends of the first and second flexible tubes 28, 26 may be joined with any suitable fasteners or fastening methods to provide a connection therebetween. The first and second flexible tubes 28, 26 may be fabricated from any suitable material, including, but not limited to, nitinol, stainless steel, and plastic / polymer. In some embodiments, the first and second flexible tubes 28, 26 are laser cut from hypodermic tubing.

[0021] The pre-configured state of the steerable sheath 12 may be the straight tube configuration shown in FIG. 3B. For example, the illustrated steerable sheath 12 may be provided by positioning the first flexible tube 28 relative to the second flexible tube 26 such that the first flexible tube 28 is concentrically nested within the second flexible tube 26 and is at least partially axially aligned with the second flexible tube 26. The steerable sheath 12 may be configured to be actuatable to bend in opposite directions, as shown in FIGS. 3C-3F. In other words, the steerable sheath 12 may be configured to form a bend in one plane. Alternatively, in another embodiment, the steerable sheath 12 may be configured to form a bend along a three-dimensional curved arc.

[0022] Configuring the first and second flexible tubes 28, 26 to employ the aforementioned concentric agonist-antagonist actuation scheme can be achieved by creating a deflectable portion (e.g., a flexible portion, a selectively weakened portion, etc.) in each of the first and second flexible tubes 28, 26 that includes a region of relatively low stiffness (e.g., a flexible “spine” of material) thereon. Thus, the first flexible tube 28 may include a first deflectable portion 40 and a first tubular sidewall portion 38 extending between a distal end 42 and a proximal end 44. Similarly, the second flexible tube 26 may include a second deflectable portion 30 and a second tubular sidewall portion 32 extending between a distal end 34 and a proximal end 36, thereby forming a flexible portion of the second flexible tube 26. In some embodiments, particularly in accordance with the agonist-antagonist actuation scheme described above, the first and second flexible tubes 28, 26 are joined at a location distal to the first and second deflectable portions 40, 30. For example, the first and second flexible tubes 28, 26 may be secured to one another at a location between the distal tip of the steerable sheath 12 (e.g., the tip of the distal end 22 of the steerable sheath 12) and the first and second deflectable portions 40, 30.

[0023] To provide the first and second deflectable portions 40, 30, each of the first and second flexible tubes 28, 26 may have material removed (e.g., by laser cutting), thereby forming a flexible "spine" of sidewall material in each of the first and second flexible tubes 28, 26. With this configuration, the first and second flexible tubes 28, 26 are axially stiff along the (respective) first and second tubular sidewall portions 38, 22 and axially compliant along the (respective) first and second deflectable portions 40, 30. The first and second deflectable portions 40, 30 may be configured such that the first and second flexible tubes 28, 26 are characterized by asymmetric elasticity therebetween (e.g., the first elasticity is lower than the second elasticity). This asymmetric resilience allows the first and second flexible tubes 28, 26 to bend (as a result of actuation) along the first and second tubular sidewall portions 38, 32 (respectively).

[0024] In some embodiments, the first and second deflectable portions 40, 30 are obtained by laser machining a slit pattern into the respective sidewalls along a portion of the length of the steerable sheath 12 proximal to the distal end 22 of the steerable sheath 12. In other words, the first and second flexible tubes 28, 26 may have a first series of cutouts and a second series of cutouts (respectively) spaced longitudinally along the (respective) first and second deflectable portions 40, 30, thereby forming a respective spine of flexible sidewall material in each of the first and second flexible tubes 28, 26. In the example configuration of Figures 3A-3D, the slit pattern in the first and second flexible tubes 28, 26 is formed by rectangular notches cut from the sidewalls of the tubes. These notches leave intact the first tubular sidewall portion 38 of the first flexible tube 28 and the second tubular sidewall portion 32 of the second flexible tube 26. Accordingly, the first and second deflectable portions 40, 30 may each include a series of cutouts spaced along the longitudinal axis 92 of the steerable sheath 12.

[0025] 3E and 3F, the first and second deflectable portions 40, 30 are obtained by laser machining a serpentine profile into the respective sidewalls along the length of the steerable sheath 12 proximal to the distal end 22 of the steerable sheath 12. Thus, the first and second deflectable portions 40, 30 may each comprise a serpentine profile of material excised from the first and second flexible tubes 28, 26 (respectively).

[0026] In some embodiments, the first and second flexible tubes 28, 26 are fixed to one another (e.g., at their distal ends 42, 34) such that the first and second deflectable portions 40, 30 are angularly oriented in directions that are offset from one another by an angle of 180 degrees or less relative to the longitudinal axis 38 (shown in FIGS. 3C and 3D ) of the steerable sheath 12. For example, the first and second deflectable portions 40, 30 may be oriented in opposite radial directions relative to the longitudinal axis 92 of the steerable sheath 12. In another embodiment, the relative angular orientation between the first and second deflectable portions 40, 30 about the longitudinal axis 92 is between 180 degrees and 0 degrees. In some embodiments, the relative angular orientation between the first and second deflectable portions 40, 30 is 180 degrees. In another embodiment, the relative angular orientation between the first and second deflectable portions 30, 30 about the longitudinal axis 92 can be adjusted to any desired relative angular orientation to achieve an optimal bending profile of the distal end 22 of the steerable sheath 12. Thus, the first and second deflectable portions 40, 30 can be opposed.

[0027] Because the first and second flexible tubes 28, 26 are connected at the distal end 34 of the second flexible tube 26 and the distal end 42 of the first flexible tube 28 (thereby forming a connection at the distal end 22 of the assembled steerable sheath 12), the steerable sheath 12 can be actuated to cause or effect bending along its length by applying an axial force (e.g., an axial push and / or pull) to the first flexible tube 28 and / or the second flexible tube 26, or to both the first and second flexible tubes 28, 26, sequentially or simultaneously. For example, translating the proximal ends 44, 36 of the first and / or second flexible tubes 28, 26 relative to one another causes a bending motion at the distal end 22 of the steerable sheath 12 along a bending plane or arc defined by the first and second deflectable portions 40, 30, thereby steering the distal end 22 of the steerable sheath 12 in two directions. Thus, the steerable sheath 12 may be actuatable to create a bend by axially translating the first flexible tube 28 relative to the second flexible tube 26 (or vice versa). In other words, the steerable sheath 12 may be actuatable to create a bend by relative axial translation between the first flexible tube 28 and the second flexible tube 26. As will be described in more detail below, the direction in which the steerable sheath 12 bends may be determined by the push / pull direction of the actuation force applied to the first and / or second flexible tubes 28, 26.

[0028] 3C and 3D, the push / pull directions along which actuation forces are applied are shown relative to the user. Specifically, actuation may be performed via the user interface 70, as described in more detail below with reference to FIGS. 9A-13H. Accordingly, an actuation force applied in the "push" direction is applied along the longitudinal axis 92, away from the user (e.g., toward the distal end 22 of the steerable sheath 12). Accordingly, an actuation force applied in the "pull" direction is applied along the longitudinal axis 92, toward the user (e.g., away from the distal end 22 of the steerable sheath 12). Following this convention, in FIG. 3C, a push force 93 is applied to the first flexible tube 28 (e.g., at its proximal end 44), and a pull force 91 is applied to the second flexible tube 26 (e.g., at its proximal end 36). Similarly, in FIG. 3D, a pulling force 97 is applied to the first flexible tube 28 and a pushing force 95 is applied to the second flexible tube 26 .

[0029] In some embodiments, as generally shown in Figures 3C and 3D, the push / pull forces applied to the first and second flexible tubes 28, 26 can be achieved by applying an axial force to both tubes simultaneously. In other embodiments, as shown in Figures 3E and 3F, the push / pull forces applied to the first and second flexible tubes 28, 26 are relative and, therefore, can be achieved by applying an axial force to only one of the tubes. Thus, the actuation force applied to the proximal end 44 of the first flexible tube 28 and the proximal end 36 of the second flexible tube 26, as shown in Figures 3C and 3D, can be achieved by applying one of the shown push / pull forces.

[0030] As a first example, as shown in Figure 3E and also in Figure 5D, the steerable sheath 12 may be actuated to form a bend such that the distal end 22 is steered along a path 96 by applying a pulling force 97 in a direction 98 (shown in Figure 5D) to the proximal end 44 of the first flexible tube 28 while holding the second flexible tube 26 in a fixed axial position. Alternatively, such movement may be achieved by applying a pushing force 95 in a direction 99 to the proximal end 36 of the second flexible tube 26 while holding the first flexible tube 28 in a fixed axial position.

[0031] 3F and further shown in FIG. 5E, the steerable sheath 12 may be actuated to form a bend such that the distal end 22 is steered along a path 94 by applying a pushing force 93 to the proximal end 44 of the first flexible tube 28 in a direction 99 (shown in FIG. 5E) while holding the second flexible tube 26 in a fixed axial position. Alternatively, such movement may be achieved by applying a pushing force 91 to the proximal end 36 of the second flexible tube 26 while holding the first flexible tube 28 in a fixed axial position.

[0032] 4A-4C, cross-sectional views of the tube assembly 10 are shown, according to some embodiments of the present disclosure. For example, FIGS. 4A and 4B show side cross-sectional views, and FIG. 4C shows an axial cross-sectional view. As suggested above, at least a portion of the control wire 52 may be disposed within the steerable sheath 12. Thus, the control wire 52 may be disposed within the first flexible tube 28, which may be disposed within the second flexible tube 23. Each of the control wire 52, the first flexible tube 28, and the second flexible tube 26 may be axially movable relative to one another.

[0033] In some embodiments, the tube assembly 10 further includes a control wire liner (e.g., tube, conduit, pipe, duct, etc.) 54 disposed around the control wire 52. Accordingly, the control wire liner 54 may be disposed between the control wire 52 and the first flexible tube 28. As suggested above, the first flexible tube 28 may be disposed within the second flexible tube 26. The control wire liner 54 may provide a lubricious liner layer between the first flexible tube 28 and the control wire 52, which is concentrically disposed within the basket sheath 52. Accordingly, a portion of the control wire 52 may be disposed within the lumen of the steerable sheath 12 and movable therein along the axis of the lumen of the steerable sheath 12. To perform the stone extraction procedures described herein, the first flexible tube 28 and the second flexible tube 26 may each have a wall thickness of about 50 to about 125 μm.

[0034] 5A-5F, according to some embodiments of the present disclosure, the steerable sheath 12 may include two or more sections. For example, the steerable sheath 12 may include a steerable section 14 in a distal region of the steerable sheath 12, which may include first and second deflectable portions 40, 30 of the first and second flexible tubes 28, 26. The steerable section 14 may thus be controlled by a user as described above. In some embodiments, the steerable sheath 12 may further include a transmission section 16 located distal to the steerable section 14. The steerable sheath 12 may thus include a steerable section 14 that is actuatable to form a bend and a transmission section 16 located distal to the steerable section 14 from the basket 50. The transmission section 16 may be the section of the steerable sheath 12 that connects the steerable section 14 to a user interface. In some embodiments, the transmission section 16 is made from the same piece of tubing as the steerable section 14. In other words, the steerable section 14 and the transmission section 16 may be formed as a single piece of material. In other embodiments, the transmission section 16 is a separate tube that is glued or welded to the steerable section 14.

[0035] In some embodiments, as shown in FIG. 5A , for applications where the path to the anatomical region is essentially straight, the transmission segment 16 may be a rigid, solid tubing. In other embodiments, as shown in FIGS. 5B and 5C , for applications where the path to the anatomical region is more tortuous, the transmission segment 16 may include a flexible segment 19 and a rigid segment 18. For example, FIGS. 5D and 5E specifically illustrate the flexible segment 19 of the second flexible tube 26. As described in more detail below, the flexibility of the flexible segment 19 may be greater than the flexibility of the rigid segment 18. As shown, the passive segment 19 of the transmission segment 16 may be located closer to the steerable segment 14 than the rigid segment 18 of the transmission segment 16.

[0036] In some embodiments, the rigid section 18 may be made of a solid tubing material. The rigid section 18 may be proximal to the steerable section 14 and the flexible section 19 and may be used as a rigid end to which a linear force may be applied (e.g., by the user interface 70) to extend the steerable sheath 12 in a path toward the anatomical region and to actuate the steerable sheath 12 to form a bend. The flexible section 19 may then be flexible enough to conform to a tortuous path toward the anatomical region.

[0037] In some embodiments, the flexible section 19 is compliant in bending so that it is passively flexible in all bending directions while maintaining relatively high torsional and axial stiffness. Additionally, the flexible section 19 may be flexible enough to allow the range of motion (e.g., bending) typically required for navigating through various patient anatomies.

[0038] In some embodiments, the flexibility of the flexible section 19 is achieved by a pattern or multiple slots laser-machined into the first and second flexible tubes 28, 23 to reduce their stiffness. In another embodiment, the flexibility of the flexible section 19 is achieved by including a tube of a more flexible polymer tubing material (e.g., polyimide, PEBAX, nylon, etc.). In yet another embodiment, the flexibility of the flexible section 19 is achieved by the same or similar methods used to provide the first and second deflectable portions 40, 30 of the first and second flexible tubes 28, 26, described above. Depending on the implementation, one or both of the flexible section 19 and the rigid section 18 may include braid reinforcement.

[0039] Continuing with reference to FIGS. 5B and 5C, the flexible segment 19 may extend over a portion of the length of the transmission segment 16, as shown in FIG. 5B, or may extend over the entire length or nearly the entire length of the transmission segment 16, as shown in FIG. 5C. The slot pattern forming the flexible segment 19 may be constant along the length of the flexible segment or may vary along the length of the flexible segment, depending on the implementation. This variation may be achieved by changing the spacing (e.g., pitch) between successive slot segments or by increasing the arc length (e.g., length of the resected portion) of each slot around the circumference of the tube. Such variation may be desirable depending on the anatomical structure being accessed. For example, a more flexible distal portion of the transmission segment 16 may be advantageous for better conforming to the native anatomy being accessed, while a less flexible proximal segment of the transmission segment 16 may be advantageous for easier pushing, torque application, and device control by the user interface 70.

[0040] 5F, the transmission section 16 of the steerable sheath 12 may further include a transition section 20 located between the flexible section 19 and the rigid section 18. The transition section 20 may provide a relatively smooth transition in the change in material properties between the flexible section 19 and the rigid section 18. For example, FIG. 5F specifically illustrates the flexible section 19, the transition section 20, and the rigid section 18 of the second flexible tube 26.

[0041] As suggested above, the tube assembly 10 may further include one or more layers of braid material disposed around the first flexible tube 28 and / or the second flexible tube 26 for reinforcement purposes.

[0042] 6A and 6B, according to some embodiments of the present disclosure, device 100 may include an outer tube 62. For example, outer tube 62 may be the ureteroscope tube of ureteroscope 60 (shown in FIGS. 10-12F). As shown, tube assembly 10 may be disposed within outer tube 62 and may extend out from a distal end 65 of outer tube 62. For example, in use, tool assembly 10 may extend through outer tube 62 such that steerable sheath 12 protrudes from distal end 65. In that sense, once steerable sheath 12 extends through outer tube 62, steerable section 14 of steerable sheath 12 (shown in FIGS. 5A-5C) may protrude from an opening formed by distal end 65 of outer tube 62. On the other hand, the flexible section 19 proximal to the active steerable section 14 will be positioned approximately within the ureteroscope 62 to facilitate protrusion of the active steerable section 14 through the distal end 65, as described above.

[0043] 6A , the outer tube 62 further includes a tool assembly 67 located on or about the distal end 65. For example, the tool assembly 67 may include a digital image and / or video sensor 68 located on the distal end 65. The image and / or video sensor 68 can capture images of the area within and surrounding the anatomical region. The image and / or video sensor 68 may be a conventional camera, a thermal camera, or both, depending on the implementation. In another example, the tool assembly 67 may include one or more light sources 69 located on the distal end 65. The one or more light sources 69 may be, for example, LED light sources or fiber optic light sources.

[0044] In some embodiments, the distal end 65 further includes openings to facilitate the passage of other secondary tools for treatment within the anatomical region. Thus, the distal tool assembly 67 may include any suitable tools at the distal end 65 for performing the methods described herein. As an example, the distal tool assembly 67 may include a laser to perform laser lithotripsy on the stone 88, breaking it into pieces small enough to be captured by the basket 50, as shown in FIG. 6B.

[0045] In some implementations, the steerable sheath 12 may be generally long enough to traverse the length of the outer tube 62 within which it is disposed (e.g., about 700 to about 850 mm, depending on the implementation), with at least a distal portion of the steerable sheath 12 extending from an opening formed by the distal end 65 of the outer tube 62 and at least a proximal portion of the steerable sheath 12 extending from the proximal end of the outer tube 62 for interfacing with one or more actuators, as described in more detail below. In one example configuration, the active steerable section 14 of the steerable sheath 12 may be up to 25 mm in length, the flexible section 19 may be up to 100 mm in length, and the rigid section 18 (as well as the transition section 20, if implemented) may be up to 800 mm in length. Thus, the steerable sheath 12 may be generally long, with a length of up to 925 mm.

[0046] 7A-7F, a basket 50 according to some embodiments of the present disclosure is shown in detail. As mentioned above, the basket 50 may be configured to capture a stone 88, as shown in FIG. 6B. In some embodiments, the basket 50 includes several (e.g., two, three, four, five, six, etc.) wires, each having a preformed curvature and connected to one another (e.g., mechanically engaged, crimped, welded) at their distal ends to form a "cage." For example, the basket 50 may include a first wire 56, a second wire 57, a third wire 58, and a fourth wire 59. The wires 56-59 may be made of any suitable material, including, but not limited to, superelastic nitinol. In some embodiments, each of the wires 56-59 may be connected to one another at their distal ends and connected to the control wire 52 at their proximal ends. For example, the wires 56-59 may be coupled to one another at their distal ends by the basket tip 51. As a first example, as shown in FIGS. 7A-7D , the basket tip 51 may be a cylindrical member (e.g., a laser-machined nitinol tube) that houses (or is formed by) the distal ends of the wires 56-59. Thus, the wires 56-59 may be connected to one another at their distal ends via the cylindrical member. As a second example, as shown in FIGS. 7E and 7F , the basket tip 51 may be a substantially flat member (e.g., a polymeric bonding disc) that is oriented perpendicular to the longitudinal axis 92 of the steerable sheath 12. Thus, the wires 56-59 may be connected to one another at their distal ends via the bonding disc. Although the illustrated basket 50 includes four wires (e.g., wires 56-59), it will be appreciated that such illustration is exemplary and, therefore, in other embodiments of the present disclosure, the basket 50 may include more or less than four wires.

[0047] In some embodiments, wires 56-59 may be gathered at their proximal ends at basket base 49, which may be coupled to control wire 52. Control wire 52 may then extend along the length of steerable sheath 12 and interface with one or more actuators (which may be disposed on actuator 70, as described in more detail below) so as to be actuated by pushing and pulling forces. For example, such pushing forces may advance control wire 52 in direction 24, as shown in FIGS. 7C and 7E, while such pulling forces may retract control wire 52 in direction 25, as shown in FIGS. 7D and 7F. As described in more detail below, forward movement of control wire 52 may cause basket 50 to expand, extending from distal end 22 of steerable sheath 12, while retracting movement of control wire 52 may cause basket 50 to retract into distal end 22 of steerable sheath 12, contracting.

[0048] In response to such pushing force and resulting translation of the control wires 52 in direction 24, the basket 50 coupled to the control wires 52 may advance in direction 27 and protrude from the distal end 22 of the steerable sheath 12 (e.g., from an opening formed in the distal end 22) to expand to the configuration shown (e.g., the "released state"). Conversely, in response to such pulling force and resulting translation of the control wires 52 in direction 25, the basket 50 may retract in direction 29 and retract into the opening formed in the distal end 22 to contract to the "collapsed state" to capture (e.g., grasp, encapsulate, hold, etc.) a stone 88 to be endoscopically removed. Such expansion and / or contraction may be facilitated by the advancement and / or retraction (respectively) of the control wires 52 coupled to the basket 50 at the basket base 49. Thus, forward movement of the control wire 52 (in response to the above-mentioned pushing force on the control wire 52) can cause the basket 50 to protrude from the opening formed by the distal end 22 of the steerable sheath 12 and expand, while retraction movement of the control wire 52 (in response to the above-mentioned pulling force on the control wire 52) can cause the basket 50 to retract into the opening formed by the distal end 22 and contract.

[0049] Thus, the basket 50 can protrude from and retract into the openings formed by the distal end 22 of the steerable sheath 12 in response to actuation of the control wires 52. In other words, when the basket 50 retracts into the openings, reducing the overall dimensions of the basket 50, the openings formed by the distal end 22 can apply an encapsulating force at their inner edges to the wires 56-59 of the basket 50. For example, when the control wires 52 are actuated by a pulling force, the radial force exerted on the wires 56-59 by the openings in the distal end 22 can cause the basket 50 to contract to a collapsed state, which can be used to encapsulate a stone 88 located within the inner boundary of the basket 50. As a corollary, when the basket 50 protrudes from the openings in the distal end 22 due to a pushing force on the control wires 52, at least a portion of that radial force is removed, allowing the basket 50 to passively expand to a released state.

[0050] In some embodiments, as shown in FIGS. 7A and 7B , basket 50 is made from a thin-walled nitinol tube that is laser machined in a section of the proximal end of the tube with several linear slots or slits (e.g., including linear slot 47) arranged axially along the length of the tube. As described above, forward movement of control wires 52 (in response to the aforementioned pushing force on control wires 52) can cause basket 50 to protrude from the opening formed by distal end 22 of steerable sheath 12 and expand to a relaxed state. For example, forward movement of control wires 52 can axially compress basket base 49. When basket base 49 is axially compressed, the spines defined by the linear slots (e.g., four wires 56-59) buckle outward, causing basket 50 to expand to a relaxed state as shown in detail in FIG. 7B . In some embodiments, basket 50 is configured to be annealed (e.g., heated above its austenite transition temperature) while in the relaxed state so that the illustrated expanded shape of basket 50 is retained. In some embodiments, particularly when the basket 50 is configured as shown, the control wires 52 are an extension of the basket 50. That is, the control wires 52 and the basket 50 may be provided as a single component.

[0051] In some embodiments, the number of slots machined into the tube determines the number of spines that make up the expanded cage. For example, as shown in Figures 7A and 7B, basket 50 includes four wires 56-59. Accordingly, basket 50 may include four corresponding slots (including slot 47).

[0052] As described above, retraction of the control wires 52 (in response to the aforementioned pulling force on the control wires 52) can retract the basket 50 into the opening formed by the distal end 22, causing it to collapse and collapse. In some embodiments, as shown in FIG. 7D , the basket 50 can be retracted inside the steerable sheath 12, thereby collapsing the aforementioned spines (e.g., wires 56-59) and causing the basket 50 to collapse and collapse. For example, the diameter of the basket 50 in its collapsed state (e.g., if the basket 50 is formed as a tube as shown in FIG. 7A ) can be smaller than the inner diameter of the first flexible tube 28 of the steerable sheath 12, thereby allowing the basket 50 to be fed through the proximal end of the steerable sheath. In another embodiment, as shown in FIG. 7F, the basket 50 may be retracted inside the steerable sheath 12 until the basket tip 51 (e.g., when provided as a substantially flat member) contacts the distal end 22 of the steerable sheath 12.

[0053] 8A and 8B, an apparatus 100 is shown being used to extract a stone 88 from within a patient's kidney 84, according to some embodiments of the present disclosure. For example, the steerable sheath 12 may be advanced within the patient's urinary system 85. Specifically, advancing the steerable sheath 12 within the patient's urinary system 85 may include advancing the steerable sheath 12 within the patient's ureter 82 toward a calyx 86 of the patient's kidney 84, thereby positioning the distal end 22 of the steerable sheath 12 within or near the calyx 86. Accordingly, one exemplary method of extracting a stone 88 may include, as a first step, inserting the outer tube 62 into the patient (e.g., extending it in the direction 117), thereby positioning the distal end 65 of the outer tube 62 within or near the patient's calyx 86. For example, the outer tube 62 may be extended into the ureter 82 (using the bladder 80 as an entry point) and directed toward the calyces 86 of the patient's kidney 84, thereby positioning the distal end 65 of the outer tube 62 within or near the calyces 86. This exemplary method may alternatively be performed without the outer tube 62 (i.e., achievable with just the steerable sheath 12). The various components of the device 100 (particularly the tool assembly 10) may be sized and configured for accessing and navigating such anatomical regions within a patient.

[0054] A second step of the exemplary method may include inserting the tube assembly 10 into the outer tube 62 and extending it through the outer tube 62 until at least a portion of the steerable sheath 12 protrudes from the distal end 65. It should be appreciated that the tube assembly 10 may be extended into the outer tube 62 before, during, or after the outer tube 62 is extended toward the renal calyx 86. It should also be appreciated that in some embodiments, the device 100 does not include the outer tube 62, and thus the tube assembly 10 itself may be inserted into the patient, thereby positioning the distal end 22 of the steerable sheath 12 within or near the patient's renal calyx 86. That is, the tool assembly 10 itself may be extended in the direction 117 to accomplish the methods described herein. Finally, as shown, the basket 50 may be positioned within the renal calyx 86 and operable to extract the stone 88.

[0055] A third step of the exemplary method may include advancing basket 50 relative to steerable sheath distal end 22, thereby causing the basket to protrude through the opening formed by distal end 22 and expand to the released state described above. For example, the third step may include advancing control wire 52 in direction 24, thereby advancing basket 50 in direction 27 and expanding it to the released state.

[0056] A fourth step of the exemplary method may include actuating and / or rotating the steerable sheath 12 to advance the basket 50 toward the stone 88. For example, the steerable sheath 12 may be actuated to form bends along paths 94 and 96 as described above. Additionally, the tube assembly 10 itself may be rotated (e.g., rotation 112) about a circumferential axis defined by the undeflected proximal portion of the steerable sheath 12. In other words, the rotation of the steerable sheath 12 causes circumferential translation of the basket 50.

[0057] A fifth step of the exemplary method may include retracting (at least a portion of) the basket 50 into the distal end 22 by retracting the control wire 52 in the direction 25 as described above, thereby capturing the stone 88 by retracting the basket in the direction 29 and shrinking it to a collapsed state.

[0058] A sixth step of the exemplary method may include removing the tube assembly 10 (along with the basket 50 and trapped stone 88) from the patient. That is, the tube assembly may be withdrawn in direction 116.

[0059] Thus, the present disclosure provides a method of performing endoscopic surgery, the method including the steps of providing a steerable sheath 12, a control wire 52 disposed within the steerable sheath 12, and a basket 50 disposed on the control wire; forming a bend in the steerable sheath 12 such that the distal end 22 of the steerable sheath 12 is steered toward an anatomical region within a patient (which may be the patient's kidney 84, a calyx 86 therein, or the region of a stone 88 therein, among other regions); advancing the control wire 52 relative to the steerable sheath 12, and retracting the control wire 52 relative to the steerable sheath 12, whereby the basket 50 retracts and contracts into the distal end 22 of the steerable sheath 12, thereby retaining the object within the basket 50. Additionally, the above-described method provided in the present disclosure may include the step of advancing the steerable sheath 12 within the ureter 82 (using the bladder 80 as an inlet) toward a calyx 86 of a kidney 84 of the patient, thereby positioning the distal end 65 of the outer tube 62 within or near the calyx 86. In this manner, the basket 50 may be manipulated as described above to retain the stone 88 .

[0060] 9A-9C, according to some embodiments of the present disclosure, device 100 may further include a user interface 70 coupled to tube assembly 10. For example, user interface 70 may be a handle. Depending on the implementation, user interface 70 may include one or more actuators (or may be manually operated) to enable a user to exercise various degrees of freedom associated with functions of steerable sheath 12 and / or basket 50 disposed thereon (e.g., rotating 112 tube assembly 10, extending and retracting tube assembly 10 in directions 116, 117, steering steerable sheath 12 along paths 94, 96, and, as described above with reference to FIG. 8B , moving control wires 52 in directions 24, 25 to advance or retract basket 50 in directions 27, 29). In other words, the user interface 70 may include actuators associated with expanding (relaxing) and / or contracting (collapsed) the basket 50, forming bends in the steerable sheath 12 to steer the distal end 22 and the basket 50 disposed thereon, advancing and / or retracting the tube assembly 10 (e.g., the steerable sheath 12 and the basket 50 disposed thereon) relative to the outer tube 62, and rotating the tube assembly 10 (which may be a rotation about an axis defined by the lumen of the outer tube 62 in which the tube assembly 10 is disposed).

[0061] As suggested above, linear movement of the control wires 52 relative to the steerable sheath 12 within which the control wires 52 are concentrically disposed can cause the basket 50 to extend and / or retract into the opening formed by the distal end 22 of the steerable sheath 12, thereby causing the basket 50 to expand and / or contract. Such linear movement of the control wires 52 relative to the steerable sheath 12 can be actuated by a basket actuator 71. In some embodiments, the basket actuator 71 is a linear sliding member (e.g., a plunger, button, etc.) operated by upstrokes and downstrokes, the linear sliding member being linearly adjustable along an axis parallel to an axis defined by at least a portion of the control wires 52. For example, the basket actuator 71 can be rigidly coupled to the control wires 52 and / or the control wire liner 54. During operation of basket actuator 71, user interface 70 can hold steerable sheath 12 in a fixed position relative to linear motion imparted to control wires 52 and / or control wire liners 52, thus causing basket 50 to extend (by a downstroke) out of steerable sheath 12 and / or retract (by an upstroke) into steerable sheath 12. In another embodiment, linear motion of control wires 52 relative to steerable sheath 12 is caused by a rotary-to-linear mechanism described below with respect to steerable sheath actuator 72 of user interface 70.

[0062] In some embodiments, basket actuator 71 may include a biasing member (e.g., a spring return element) 75 that biases basket 50 toward either the passively released state or the passively collapsed state. For example, biasing member 75 may be configured to bias the basket toward the passively collapsed state by a biasing force that acts against manipulation of basket actuator 71 to return basket actuator 71 to its initial state (and return basket 50 from the released state to the collapsed state) when an external force is no longer applied to basket actuator 71 (e.g., when the user no longer presses basket actuator 71 into housing 76 of user interface 70). In other words, biasing member 75 causes an upstroke of a linear sliding member (e.g., plunger) of basket actuator 71 with a biasing force and counters a downstroke with a biasing force. In some embodiments, biasing member 75 operates in the opposite direction, causing a downstroke with a biasing force and countering an upstroke with a biasing force.

[0063] As suggested above, actuation of the steerable sheath 12 (and thereby steering of the distal end 22) can be caused by linear displacement of the steerable sheath inner tube 28 relative to the steerable sheath outer tube 26 (or linear displacement of the steerable sheath outer tube 26 relative to the steerable sheath inner tube 28). In some embodiments, such linear displacement is caused by a steerable sheath actuator 72. The steerable sheath actuator 72 can include a rotary-to-linear mechanism (e.g., a lead screw, a slider crank, a barrel cam, etc.). For example, the rotary-to-linear mechanism can include a lead nut 73 that engages with a lead screw 74. The lead nut 73 can be rotated by a user of the user interface 70 (e.g., by manually rotating a knob 71 on the user interface 70), resulting in linear translation of the lead screw 74. The lead screw 74 may then be rigidly coupled to either the steerable sheath outer tube 26 or the steerable sheath inner tube 28 in order to translate the position of the steerable sheath inner tube 28 (respectively) relative to the steerable sheath outer tube 26.

[0064] In some embodiments, the lead screw 74 is rigidly coupled to the steerable sheath inner tube 28, while a portion of the housing 76 of the user interface 70 fixes the position of the steerable sheath outer tube 26. Thus, rotating the lead nut 73 results in linear movement of the steerable sheath inner tube 28 relative to the steerable sheath outer tube 26, thereby deflecting the steerable sheath 12 to form a bend and steering the distal end 22. Rotating the lead nut 73 may be accomplished by a knob 77 on the user interface 70. In another embodiment, linear displacement of the steerable sheath inner tube 28 relative to the steerable sheath outer tube 26 (or linear displacement of the steerable sheath outer tube 26 relative to the steerable sheath inner tube 28) may be caused by a linear sliding member, as described above with respect to the basket actuator 71.

[0065] In some embodiments, the user interface 70 includes a mechanism for passively "locking" the linear movement of the control wires 52 relative to the steerable sheath 12 when the basket actuator 71 is not in use and / or the linear displacement of the steerable sheath inner tube 28 relative to the steerable sheath outer tube 26 (or the linear displacement of the steerable sheath outer tube 26 relative to the steerable sheath inner tube 28) when the steerable sheath actuator 72 is not in use. Passively locking such linear movement can be achieved by a non-backdrive feature of the basket actuator 71 and / or the steerable sheath actuator 72, a spring detent mechanism, a ratchet / pawl mechanism, a friction locking mechanism, or the like.

[0066] In some embodiments, the linear sliding member (whether configured as the basket actuator 71, the steerable sheath actuator 72, or both) includes a switch-toggle mechanism for operating the basket actuator 71 and / or the steerable sheath actuator 72 through two separate user interactions with the linear sliding member. For example, the switch-toggle mechanism may be actuated to rotate and lock the cam body and compress the biasing member 75 at a first time (e.g., to deploy the basket 50 to a released state or to form a predefined bend in the steerable sheath 12). At a second time, the switch-toggle mechanism may be actuated to rotate and unlock the cam body, with the compressed biasing member 75 urging the linear sliding member to move the basket 50 to a collapsed state or to remove the bend in the steerable sheath 12.

[0067] 10 , an apparatus 100 according to some embodiments of the present disclosure is shown, which includes a tube assembly 10, a user interface 70, and a ureteroscope 60. As shown, the ureteroscope 60 may be coupled to the user interface 70 and the tube assembly 10. In some embodiments, the ureteroscope 60 includes a ureteroscope handle 61 coupled to an outer tube 62 at a ureteroscope hub 63. In some alternative embodiments, the ureteroscope 60 is instead a rigid cystoscope or nephroscope.

[0068] In some embodiments, the user interface 70 is coupled to the ureteroscope 60 via a ureteroscope working channel mount 78 of the user interface 70, which may be coupled to the working port 66 of the ureteroscope 60. The ureteroscope working channel mount 78 may thus be configured to mechanically secure and spatially position the user interface 70 relative to the ureteroscope 60. The tube assembly 10 may then be threaded through the working port 66, the ureteroscope hub 63, and through the lumen of the outer tube 62, protruding at least partially from the opening formed by the distal end 65 of the outer tube 62. The basket 50 may then be delivered through the ureteroscope 60 and protruding from the distal end 22 of the steerable sheath 12 to perform the methods described herein.

[0069] In some embodiments, the user interface 70 includes a mechanism for rigidly coupling with the working port 66 through which the tubing assembly 10 is threaded. For example, such a mechanism may be a female luer connector that threads onto a male luer fitting formed on the working port 66. As another example, the user interface 70 itself may feature a strain relief that is free to move and limits the tension on the basket 50 as it exits the user interface 70. As shown, the user interface 70 may be coupled to the working port 66 of the ureteroscope 60.

[0070] In some embodiments, the overall outer diameter of the steerable sheath 12 (e.g., the outer diameter of the second flexible tube 26 or the outer diameter of the outermost component disposed around the second flexible tube 26) may be smaller (e.g., 1.2 mm) than the working port 66. However, to allow for adequate fluid flow within the outer tube 62, as may be required during normal operation of the ureteroscope 60, the overall outer diameter of the steerable sheath 12 may be approximately 1 mm or less.

[0071] 11A-11H, exemplary implementations of the basket actuator 71 and steerable sheath actuator 72 of the user interface 70 are shown, according to some embodiments of the present disclosure. FIGS. 11A-11D show the device 100 operated by the user interface 70 coupled with a tube assembly 10, while FIGS. 11E-11H show the device 100 similarly operated in combination with a ureteroscope 60. FIG. 11A shows the device 100 in a pre-configured state, in which the basket 50 has not yet protruded from the distal end 22 of the steerable sheath 12. FIGS. 11B and 11E show the basket actuator 71 being actuated with a force in the direction of 127, resulting in the basket 50 advancing in the direction of 27 and protruding from the distal end 22 of the steerable sheath 12, creating a released state of the basket 50. Figures 11C and 11F show the knob 71 of the user interface 70 being rotated in a first direction 118, which causes the steerable sheath actuator 72 to actuate to form a bend in the steerable sheath 12 and steer the basket 50 on the distal end 22 of the steerable sheath 12 along a path 94 relative to the longitudinal axis 92. Figures 11D and 11G show the knob 71 being rotated in a second direction 119, which causes the steerable sheath actuator 72 to actuate to form a bend in the steerable sheath 12 and steer the basket 50 on the distal end 22 of the steerable sheath 12 along a path 96 relative to the longitudinal axis 92. Figure 11H shows the basket 50 being circumferentially translated by rotating (e.g., rotating 112) the user interface 70 about a circumferential axis defined by the undeflected proximal portion of the steerable sheath 12.

[0072] In some embodiments, insertion and retraction of the tube assembly 10 is linear translation of the tube assembly 10 (e.g., movement of the tube assembly in directions 116 or 117, as shown in FIG. 8B ), which may be relative to the outer tube 62. Such linear translation may be achieved by moving the user interface 70 relative to the working port 66 on the ureteroscope hub 63 of the ureteroscope 60 (as will be described in more detail below with reference to FIGS. 10-13D ). For example, the user interface 70 may be coupled to the working port 66 by a linear bearing, which allows the user interface 70 to maintain its coupling with the ureteroscope 60 while having a linear range of motion that allows linear translation of the user interface 70 and the coupled tube assembly 10. In this example, the linear bearing may include a locking mechanism that maintains translation of the user interface 70 relative to the ureteroscope 60 when force (e.g., manual manipulation) on the user interface 70 is removed. The linear bearing may further include a biasing member that biases the user interface 70 to a particular position relative to the ureteroscope 60, which allows for a passively inserted or passively retracted state of the tube assembly 10 relative to the outer tube 62. In another example, the user interface 70 may not be coupled to the working port 66. Instead, the tube assembly 10 may be inserted into the working port 66 and threaded through the outer tube 62 by moving the user interface 70 relative to the working port 66.

[0073] 12A-12F, a user interface 70 of a device 100 according to some embodiments of the present disclosure is shown, which includes a quick release mechanism 79 that may be selectively coupled to a ureteroscope working channel mount 78.

[0074] 12B and 12C, the ureteroscope working channel mount 78 is attached to the working port 66 of the ureteroscope 60 (by moving the ureteroscope working channel mount 78 in direction 81) before the user interface 70 is attached to the ureteroscope 60. For example, the ureteroscope working channel mount 78 is first attached to the input 83 of the working port 66.

[0075] 12D and 12E, to attach the user interface 70 to the ureteroscope 60, the tubing assembly 10 may be inserted through a ureteroscope working channel mount 78 and into the working port 66. In some embodiments, the ureteroscope working channel mount 78 includes a rubber O-ring or sealing surface that forms a watertight seal against the second flexible tube 26 of the steerable sheath 12 via an interference fit after the steerable sheath 12 of the tubing assembly 10 is inserted to prevent backflow of irrigation.

[0076] 12F, the components of user interface 70 proximal to ureteroscope working channel mount 78 (including quick release mechanism 79) may be pushed (in the direction of 81) into ureteroscope working channel mount 78. As shown, this may result in steerable sheath 12 protruding from distal end 65 of outer tube 62 of ureteroscope 60. This may also result in quick release mechanism 79 selectively engaging ureteroscope working channel mount 78.

[0077] In some embodiments, the quick release mechanism 79 includes a deflection mechanism and a retaining surface that allows the proximal components of the user interface 70 to be pressed into and seated within the ureteroscope working channel mount 78, and the retaining surface prevents such components of the user interface 70 from being pulled out. For example, to remove the proximal components of the user interface 70 from the ureteroscope working channel mount 78, a release tab 89 of the quick release mechanism 79 may be depressed, thereby releasing the constraint of the retaining surface and allowing the proximal components of the user interface 70 to be pulled out.

[0078] 13A-13F, a user interface 70 of the device 100 is shown according to several alternative embodiments of the present disclosure. In some embodiments, the user interface 70 includes a lever 165, which may be thumb-actuated. The lever 165 can be used to axially translate the first and second flexible tubes 28, 26 relative to one another (as previously described in detail) and actuate the steerable sheath 12 to form a bend, thereby steering the basket 50 toward an anatomical region. As shown, the lever 165 drives a rotary-to-linear mechanism (e.g., a scotch yoke mechanism, a slider-crank mechanism, etc.) 167 to generate the required axial translation of the first and second flexible tubes 28, 26 relative to one another. As a first example, rotating lever 165 clockwise, as shown in Figure 13A, actuates steerable sheath 12 to form a bend, thereby steering distal end 22 of steerable sheath 12 along path 94, as shown in Figure 13B. As a second example, rotating lever 165 counterclockwise, as shown in Figure 13C, actuates steerable sheath 12 to form a bend, thereby steering distal end 22 of steerable sheath 12 along path 96, as shown in Figure 13D. Thus, in some embodiments, the device includes a mechanical transmission that converts rotational motion into linear (i.e., axial) translation between first flexible tube 28 and second flexible tube 23, whereby steerable tool 20 can be actuated to form a bend.

[0079] In some embodiments, the user interface 70 further includes a trigger 146, which may be actuated by squeezing the trigger with a finger. The trigger 146 may be used to expand the basket 50 to its released state or retract it to its collapsed state, as described above. As shown in FIGS. 13E and 13F , the trigger 146 may be biased by a tension spring and, when depressed, may advance the control wires 52 within the steerable sheath 12, causing the basket 50 to protrude from the distal end 22 of the steerable sheath 12 and expand to its released state. When the trigger 146 is released, the tension spring retracts the control wires, thereby retracting the basket 50 into the distal end 22 of the steerable sheath 12 and forming the collapsed state of the basket 50.

[0080] 14A and 14B, according to some alternative embodiments of the present disclosure, the ureteroscope 60 of the device 100 can be a rigid ureteroscope. For example, in certain cases in urology, it can be useful to pass the tubing assembly 10 through a rigid or semi-rigid endoscopic platform. Percutaneous nephrolithotomy (PCNL) is a surgical kidney stone removal procedure in which a rigid endoscope is introduced into the kidney through an incision in the patient's back, and a suite of tools (laser, lithotriptor, and basket) for removing the stone (e.g., stone 88) are introduced through the rigid endoscope.

[0081] In such embodiments, the transmission section 16 of the steerable sheath 12 may be characterized by high axial, torsional, and bending stiffness. In other words, the transmission section 16 of the steerable sheath 12 may be a rigid, solid tubing material, as described above with respect to FIG. 5A. In such embodiments, the length of the transmission section 16 may be sufficient to traverse a rigid endoscope through which the tube assembly 10 is threaded.

[0082] In another embodiment, passive flexibility along the transmission section 16 may be desirable to allow for accidental misalignment between the steerable basket and the rigid endoscope through which it is threaded. This may be achieved by including a flexible section 19 (as shown in FIGS. 5B and 5C ) along some or all of the transmission section. In such an embodiment, passive flexibility may be achieved by laser machining a series of alternating slots, with each row of slots rotated 90 degrees from the previous row. The flexibility of the flexible section 19 may be modified by carefully selecting the spacing between the slots (i.e., pitch) and the arc length of each slot along the circumference of the tube (i.e., the length of the resected portion). In some embodiments, the angle between consecutive rows of slots may be different from 90 degrees, causing consecutive slots to “twist” about the longitudinal axis 92 of the steerable sheath 12.

[0083] 15 , according to some embodiments of the present disclosure, the user interface 70 of the device 100 may include a robotic actuator mechanism 120. For example, the various actuations performed by the user interface 70 described above may be achieved by the robotic actuator mechanism 120. The robotic actuator mechanism 120 may be controlled by a controller communicatively coupled to the robotic actuator mechanism 120 via a wired or wireless connection. Depending on the implementation, the robotic actuator mechanism 120 may be a component of the user interface 70 or may be used in place of a user interface in the device 100. For example, in the illustrated exemplary embodiment, the robotic actuator mechanism 120 is shown interacting with the steerable sheath 12 and control wires 52 of the tube assembly 10, and includes a chassis defined by a chassis front plate 126 and a chassis rear plate 130. In some embodiments, the chassis front plate 126 and / or the chassis rear plate 130 may be used to couple the robotic actuator mechanism 120 to the user interface 70 such that the robotic actuator mechanism 120 can function as the actuation component of the user interface 70 described above. In other embodiments, the chassis front plate 126 and / or the chassis rear plate 130 may be used to couple the robotic actuator mechanism 120 to the ureteroscope 60. For example, the chassis front plate 126 and the chassis rear plate 130 may be coupled to the ureteroscope handle 61, the ureteroscope hub 63, and / or the working port 66.

[0084] As an example of the operation of the robotic actuator mechanism 120, actuation of the steerable sheath 12 to form a bend may be performed by a lead screw transmission of the robotic actuator mechanism 120. In this example, the first flexible tube 28 is attached to a rear fixed mount 129, and the second flexible tube 26 is attached to an actuated mount 128 located between a front fixed mount 127 and a rear fixed mount 129, which are fixed relative to each other and separated by a precision steel guide rail. The steerable sheath deflection motor 123 attached to the front fixed mount 127 is coupled to a lead screw by a spur gear transmission, and a lead nut on the actuated mount 128 allows rotation of the lead screw to translate the actuated mount 128 relative to the front fixed mount 127 and the rear fixed mount 129. As the steerable sheath deflection motor 123 rotates, the linear bearings of the actuated mount 128 slide on the above-mentioned guide rails, causing relative translation between the second flexible tube 26 and the first flexible tube 28.

[0085] As another example, rotation of the tube assembly 10 (e.g., rotation 112) may be accomplished by the robotic actuator mechanism 120 rotating both the first flexible tube 28 and the second flexible tube 26 simultaneously. This prevents a rotational offset between the first flexible tube 28 and the second flexible tube 26, which could interfere with the deflection of the steerable sheath tube 12. In this example, the steerable sheath rotation motor 122, mounted on the forward fixed mount 127, is coupled to a square shaft by a spur gear transmission. This square shaft transmits rotation to drive spur gears mounted on both the actuated mount 128 and the aft fixed mount 129 (each spur gear is coupled to its respective mount via a rotary bearing interface). Each of these drive spur gears features a square bore with sufficient clearance to slide linearly relative to the square shaft when the actuated mount 128 is translated. The drive spur gears interface with driven spurs on their respective mounts, with the second flexible tube 26 attached to the bore of the driven spur gear on the actuated mount 128 and the first flexible tube 28 attached to the bore of the driven spur gear on the aft fixed mount 129. When the steerable sheath rotation motor 122 is actuated to rotate the square shaft, both the first flexible tube 28 and the second flexible tube 26 rotate by the same amount.

[0086] As yet another example, the advancement and / or retraction of basket 50 is accomplished by friction drive transmission 125. In this example, control wire 52 is sandwiched between a motor-driven drive roller and an idler roller of friction drive transmission 125. A basket feed motor 121, mounted on a rear fixed mount 129, is coupled to the rollers of friction drive transmission 125 by a bevel gear transmission. In another configuration, robotic actuator mechanism 120 drives the extension and / or retraction of basket 50 by a second lead screw transmission, which operates in a manner similar to the manner in which robotic actuator mechanism 120 effects the deflection of steerable sheath 12.

[0087] Furthermore, in another example, insertion and retraction of the entire tube assembly 10 may be enabled by an insertion / retraction motor 124, which translates all of the aforementioned motors 121, 122, 123, and 124, friction drive transmission 125, and mounts 127, 128, and 129 relative to a fixed outer chassis defined by a chassis front plate 126 and a chassis rear plate 130. The insertion / retraction motor 124, mounted to the chassis rear plate 130, back-drives a lead screw through a mechanical coupling that interfaces with a lead nut on the rear fixed mount 129, and the rotation imparted to the lead screw translates the rear fixed mount 129, front fixed mount 127, and actuated mount 128 as a unit. Rotation is constrained by linear bearings in front and rear fixed mounts 127 and 129 which interface with precision guide rails attached to chassis front plate 126 and chassis rear plate 130, respectively.

[0088] While specific embodiments of the novel and useful Endoscopic Lithotripsy Method and Apparatus have been described above, such references are not intended to be construed as limitations on the scope of the invention.

Claims

1. a steerable sheath in which a first flexible tube is concentrically nested within a second flexible tube; a control wire disposed within the steerable sheath and movable within the steerable sheath along a longitudinal axis of the steerable sheath; a basket disposed on the control wire and positioned at least partially within the steerable sheath, the basket including a plurality of wires; Including, the first flexible tube includes a first deflectable portion and the second flexible tube includes a second deflectable portion, the first and second deflectable portions being selectively weakened portions of the first and second flexible tubes that are angularly oriented in directions offset from one another by an angle of 180 degrees or less relative to a longitudinal axis of the steerable tool; the first and second flexible tubes are joined at a location distal to the first and second deflectable portions; the steerable tool is actuatable to cause the first flexible tube and the second flexible tube to axially translate relative to one another to form a bend; Forward movement of the control wire causes the basket to expand and protrude from the distal end of the steerable sheath; Retraction movement of the control wire retracts and collapses the basket into the distal end of the steerable sheath. Endoscopic device.

2. The device of claim 1 , wherein the first and second deflectable portions each comprise a serpentine profile of material cut from the first and second flexible tubes.

3. The apparatus of claim 1 , wherein the first and second deflectable portions each include a series of cutouts spaced along the longitudinal axis of the steerable tool.

4. each of the plurality of wires having a preformed bend; each of the plurality of wires being coupled to one another at their distal ends; each of the plurality of wires being coupled at its proximal end to the distal end of the control wire; 10. The apparatus of claim 1.

5. The device of claim 1 , wherein the plurality of wires are coupled together at their distal ends via a cylindrical member.

6. The device of claim 1 , wherein the wires are joined together at their distal ends via a joining disk.

7. the steerable sheath includes a steerable section actuatable to form the bend and a transmission section located farther from the basket than the steerable section; The transmission section includes a passive section and a rigid section, and the flexibility of the passive section is higher than the flexibility of the rigid section.

10. The apparatus of claim 1.

8. The apparatus of claim 7 , wherein the passive section of the transmission section is located closer to the steerable section than the rigid section of the transmission section.

9. 1. A method of performing endoscopic surgery, comprising: providing a steerable sheath, a control wire disposed within the steerable sheath, and a basket disposed on the control wire; forming a bend in the steerable sheath, wherein forming the bend steers a distal end of the steerable sheath toward an anatomical region within a patient; advancing the control wire relative to the steerable sheath, wherein advancing the control wire relative to the steerable sheath causes the basket to expand and protrude from the distal end of the steerable sheath, thereby positioning the basket around an object within the anatomical region; retracting the control wires relative to the steerable sheath, wherein retracting the control wires relative to the steerable sheath causes the basket to retract and contract into the distal end of the steerable sheath, thereby causing the basket to hold the object; A method comprising:

10. 10. The method of claim 9, further comprising advancing the steerable sheath through the patient's urinary system.

11. the step of advancing the steerable sheath within the patient's urinary system includes advancing the steerable sheath within the patient's ureter toward a calyx of the patient's kidney, thereby positioning the distal end of the steerable sheath within or near the calyx; the object is a kidney stone; The method of claim 10.

12. the steerable sheath includes a first flexible tube concentrically nested within a second flexible tube; the first flexible tube includes a first deflectable portion, and the second flexible tube includes a second deflectable portion; the first and second deflectable portions are selectively weakened portions of the first and second flexible tubes that are angularly oriented in directions offset from one another by an angle of less than or equal to 180 degrees relative to a longitudinal axis of the steerable tool; the first and second flexible tubes are joined at a location distal to the first and second deflectable portions; The method of claim 11.

13. The method of claim 12 , wherein the first and second deflectable portions comprise serpentine profiles of material cut from the first and second flexible tubes, respectively.

14. The method of claim 12 , wherein the first and second deflectable portions each include a series of cutouts spaced along the longitudinal axis of the steerable tool.

15. the basket includes a plurality of wires; each of the plurality of wires having a preformed bend; the plurality of wires are joined together at their distal ends; the plurality of wires being coupled at their proximal ends to the distal end of the control wire; The method of claim 12.

16. The method of claim 15 , wherein the wires are coupled together at their distal ends via a cylindrical member.

17. The method of claim 15 , wherein the wires are joined together at their distal ends via a joining disk.

18. a steerable sheath actuatable to form a bend; a control wire disposed within the steerable sheath and movable within the steerable sheath along a longitudinal axis of the steerable sheath; a basket disposed on the control wire and at least a portion of which is located within the steerable sheath, the basket including a plurality of wires each having a preformed curvature; Including, the plurality of wires are coupled to one another at their distal ends and to the distal end of the control wire at their proximal ends; Forward movement of the control wire causes the basket to expand and protrude from the distal end of the steerable sheath; Retraction movement of the control wire retracts and collapses the basket into the distal end of the steerable sheath. Endoscopic device.

19. the steerable sheath includes a first flexible tube concentrically nested within a second flexible tube; the first flexible tube includes a first deflectable portion, and the second flexible tube includes a second deflectable portion; the first and second deflectable portions are selectively weakened portions of the first and second flexible tubes that are angularly oriented in directions offset from one another by an angle of less than or equal to 180 degrees relative to a longitudinal axis of the steerable tool; the first and second flexible tubes are joined at a location distal to the first and second deflectable portions; the steerable tool is actuatable to cause the first flexible tube and the second flexible tube to axially translate relative to one another to form a bend; 20. The apparatus of claim 18.

20. the steerable sheath includes a steerable section actuatable to form the bend and a transmission section located farther from the basket than the steerable section; the transmission section includes a passive section and a rigid section, the passive section having a higher flexibility than the rigid section; the passive section of the transmission section is located closer to the steerable section than the rigid section of the transmission section; 20. The apparatus of claim 19.

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